Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients

Emory University

Status and phase: Terminated; Phase 4

Conditions: Stress Hyperglycemia

Treatments: Drug: Dulaglutide Injection; Other: Saline Injection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03743025

1K23GM128221-01A1 (U.S. NIH Grant/Contract)

IRB00097963

Details and patient eligibility

About

This study is a prospective randomized study to examine the effects of exposure to dulaglutide on the prevention of stress-hyperglycemia and the metabolic inflammatory response in the perioperative period.

Full description

Stress hyperglycemia is common in the perioperative period and is associated with increased risk of death postoperatively. Counterregulatory hormones and inflammatory mediators appear to modulate the acute biological response to stress, however, the pathophysiological pathways that result in stress hyperglycemia and its link to poor clinical outcomes are not well understood. At least half of non-diabetes mellitus (DM) patients undergoing cardiac surgery develop stress hyperglycemia shown to be an independent risk factor of morbidity and mortality. The current approach to treat hyperglycemia with insulin has major limitations including high resource utilization and high risk of hypoglycemia. The main goals of this study are to examine baseline and postoperative metabolic profiles of non-diabetic, coronary artery bypass grafting (CABG) patients with stress hyperglycemia and to study the effect of a long-acting glucagon-like peptide-1 receptor agonists (GLP-1 RA) on the prevention of stress-hyperglycemia and modulation of metabolic stress during cardiac surgery.

To examine whether exposure to dulaglutide, a GLP-1 RA, can improve glycemic control and ameliorate the inflammatory response to acute surgical stress, obese patients without diabetes mellitus undergoing CABG surgery will be randomized to receive either dulaglutide or placebo two to three days prior to surgery. The researchers of this study ultimately want to provide evidence to support the use of novel therapies to prevent and manage stress hyperglycemia in the inpatient setting.

Enrollment: 28 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females between the ages of 40 and 80 years
• Body mass index (BMI) ≥25
• Undergoing elective CABG surgery
• No previous history of diabetes or hyperglycemia

Exclusion criteria

• Hyperglycemia (BG>125 mg/dl or HbA1c > 6.5%) or previous treatment with antidiabetic agents
• Impaired renal function (GFR < 30 ml/min) or clinically significant hepatic failure
• Gastrointestinal obstruction expected to require gastrointestinal suction
• Patients with clinically relevant pancreatic or gallbladder disease
• Treatment with oral or injectable corticosteroid
• Mental condition rendering the subject unable to understand the possible consequences of the study
• Pregnancy or breastfeeding at time of enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups, including a placebo group

Dulaglutide Arm

Experimental group

Description:

Participants without a history of DM who are randomized to receive a single injection of dulaglutide (0.75 mg/0.5 mL solution in a single-dose pen) one to three days prior to surgery.

Treatment:

Drug: Dulaglutide Injection

Placebo Arm

Placebo Comparator group

Description:

Participants without a history of DM who are randomized to receive a single injection of a placebo (saline injection of 0.5 mL pre-drawn solution) one to three days prior to surgery.

Treatment:

Other: Saline Injection